Executive Briefing Series (formerly The Food & Drug Letter)

With drug companies increasingly outsourcing the manufacture of materials, ingredients or finished products, preparation of a rock-solid supplier quality agreement is imperative to ensure the caliber of contract suppliers. One has only to think back to 2010 and contaminated heparin from China to recall what can happen when companies don’t properly vet their suppliers. In the last issue of The Food & Drug Letter, companies learned how to qualify suppliers and format an agreement in order to avoid problems and ensure both parties can respond quickly when problems occur. This issue of F&DL focuses on what to include in each section of the quality agreement — administrative, operations, compliance and troubleshooting.

Companies need to consider all aspects of their relationship with prospective suppliers that could put them at risk for noncompliance with the FDA or increase the likelihood a poor quality or defective product reaches the marketplace.

The operations portion of the supplier quality agreement deals with quality control issues that will be ongoing during a drug’s production.

Companies need to be certain they can meet their compliance commitments with the FDA when they contract with outside suppliers.

One of the challenges drugmakers face is how to assess whether an existing supplier contract is weak.